PREVEQUINE Comprimé

Land: Canada

Taal: Frans

Bron: Health Canada

Werkstoffen:

Firocoxib

Beschikbaar vanaf:

BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.

Dosering:

57MG

farmaceutische vorm:

Comprimé

Samenstelling:

Firocoxib 57MG

Toedieningsweg:

Orale

Eenheden in pakket:

15G/50G

Prescription-type:

Prescription

Therapeutische categorie:

Chevaux

Product samenvatting:

Numéro de groupe d'ingrédients actifs (GIA) :0152300001

Autorisatie-status:

APPROUVÉ

Autorisatie datum:

2020-06-30

Bijsluiter

BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.
PREVEQUINE™ (FIROCOXIB) /PROPOSED LABELING COMPONENTS
BI Version-19JUN2020
21
DIN XXXXXXXX
PR
PREVEQUINE™
(FIROCOXIB)
TABLETS FOR HORSES
FOR VETERINARY USE ONLY
DESCRIPTION:
PrevEquine™ (firocoxib) tablets are round, beige to tan, half-scored
tablets containing
57 mg of firocoxib. Firocoxib belongs to the coxib class of
non-narcotic, non-steroidal
anti-inflammatory drugs (NSAIDs). It is a white crystalline compound
described
chemically as 3 (cyclopropylmethoxy)-4-(4-methylsulfonyl)phenyl)-5, 5-
dimethylfuranone. The empirical formula is C
17
H
20
O
5
S, and the molecular weight
is336.4 g/mol. The structural formula is shown below:
INDICATIONS:
PrevEquine™ tablets are indicated for the control of pain and
inflammation associated
with osteoarthritis in horses.
DOSAGE AND ADMINISTRATION:
(Always
provide
the
Client
Information
Sheet
with
the
prescription).
The
recommended dosage of PrevEquine™ tablets is one 57 mg tablet
administered orally
to horses weighing 360 – 600 kg, once daily for up to 14 days. For
ease of
administration, PrevEquine™ tablets may be given with food.
CONTRAINDICATIONS:
Horses with a hypersensitivity to firocoxib should not receive
PrevEquine™ tablets.
CAUTIONS:
Horses should undergo a thorough history and physical examination
before initiation
of NSAID therapy. Appropriate laboratory tests should be conducted to
establish
hematological and serum biochemical baseline data before and
periodically during
administration of any NSAID. Clients should be advised to observe for
signs of
potential drug toxicity and should be given a Client Information Sheet
with each
prescription. See Information for Owner or Person Treating Horse
section of this
package insert.
S
O
O
O
O
O
CH
3
BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.
PREVEQUINE™ (FIROCOXIB) /PROPOSED LABELING COMPONENTS
BI Version-19JUN2020
22
Treatment
with
PrevEquine™
tablets
should
be
terminated
if
signs
such
as
inappetence, colic, abnormal feces, or lethargy are observed.
As